Rectal injection device and method of operation thereof

ABSTRACT

A rectal injection device and a method of operating a rectal injection device. In one embodiment, the device includes: (1) a handle having a trigger associated therewith, (2) an extension tube extending from the handle and terminating in a head, (3) at least two needles coupled to the head and configured to move relative thereto between a retracted position and a deployed position and (4) a pullrod coupling the trigger and the needles and configured to cause the needles to move.

CROSS-REFERENCE TO RELATED APPLICATIONS

This divisional patent application claims priority to U.S. patentapplication Ser. No. 15/625,552, filed on Jun. 16, 2017, entitled“Rectal Injection Device and Method of Operation Thereof”, and claimspriority to U.S. Provisional Patent Application Ser. No. 62/350,812,filed on Jun. 16, 2016, entitled “Rectal Injection Device and Methods ofManufacture and Operation Thereof”, and further claims priority to U.S.Provisional Patent Application Ser. No. 62/408,302, filed on Oct. 14,2016, entitled “Rectal Injection Device and Methods of Manufacture andOperation Thereof”. These applications are assigned to the assignee ofthe present application and are hereby incorporated by reference intothe present application as if fully set forth herein.

TECHNICAL FIELD

This application is directed, in general, to an injection device forliquids and, more specifically, to a rectal injection device for liquidsand methods of manufacturing and operating the same.

BACKGROUND

Every year hundreds of millions of individuals worldwide suffer fromserious lower gastrointestinal (GI) diseases and disorders (e.g., fecalanal incontinence/laxity, hemorrhoids, colitis) requiring intervention.The technology incorporated in the design of gastrointestinal deviceshas seen little to no developmental progress in recent years. Indeed,biopsy forceps, polypectomy snares and fine aspiration needles have seenso little change that they are becoming commodities. Though theseconventional devices remain limited in their efficacy, the incidence ofthese disease states continues to increase.

Fecal incontinence, the involuntary loss of stool or air per anus, is acommon clinical problem, typically resulting from sphincter injury (mostoften in women during labor). According to the National Health andNutrition Examination Survey (NHANES) the prevalence of fecalincontinence in U.S. adults is approximately 10%. Nearly 18 million U.S.adults (about 1 in 12) have fecal incontinence. Further, the prevalenceapproaches nearly 50% of nursing home residents, with no effectivenon-surgical treatment. Often, fecal incontinence is a primary conditionfor motivating caregivers to move the elderly into nursing homefacilities from private residences. Social embarrassment, fear about thecause, or even a misconception that incontinence is part of the normalaging process may prevent patients from revealing these symptoms totheir healthcare providers. The severity of the condition often mandatescontinuous protection from soiling, and robs patients of their qualityof life and independence.

Over $400 million per year is spent on adult diapers and protectiveclothing in the U.S. alone. These symptoms may persist for years beforea patient vocalizes complaints and obtains relief. Adding to this is thefinancial burden to the individual and society. The healthcare cost ofincontinence among U.S. adults in 2000 was estimated at $20 billion.Over 50% of these costs are attributed to resources necessary to managethe patients' condition including nursing home and assisted-livingcaregiver salaries, and absorbent pads and diapers. The 2010 nationalannual average cost for fecal incontinence care was $4,000 per person.Treatments for fecal incontinence include fiber supplements, biofeedbackto train the sphincter, exercises to tighten the sphincter, and surgery.Unfortunately, these available treatments outside of invasive surgeryare lengthy and often ineffective. Inadequate repair or poor healing ofobstetric perineal injuries may present as anal incontinence within daysto weeks of delivery. In fact, some authors have reported an incidenceof anal incontinence after third- or fourth-degree laceration as high as40-60% of women. Various fillers, such as collagen/silicone, may beinjected to treat such laxity by increasing the pressure resistance ofthe internal sphincter.

Many other GI disorders have a major impact on health. For example,hemorrhoids—inflamed and swollen veins in the anus or lower rectum—areextremely common, accounting for some 50 million procedures performedworldwide. The two most common office-based procedures used to treatsymptomatic hemorrhoids are rubber band ligation (RBL) and sclerotherapy(SCL). RBL involves stretching an elastomeric band about a target veinsuch that it constricts and substantially halts blood flow through thevein, causing it to shrivel over time, thus reducing and eliminating thehemorrhoid. SCL involves injecting a sclerosing solution into a targetvein, which causes the vein to shrivel over time, again reducing andeliminating the hemorrhoid.

SUMMARY

One aspect provides a rectal injection device and a method of operatinga rectal injection device. In one embodiment, the device includes: (1) ahandle having a trigger associated therewith, (2) an extension tubeextending from the handle and terminating in a head, (3) at least twoneedles coupled to the head and configured to move relative theretobetween a retracted position and a deployed position and (4) a pullrodcoupling the trigger and the needles and configured to cause the needlesto move.

In another embodiment, the rectal injection device includes: (1) anelongated handle having a trigger coupled thereto, (2) an internaldevice syringe located within the handle, (3) an extension tubeextending from the handle and terminating in a head configured to seaton an anal dentate of a rectum, (4) at least three needles evenly spacedwithin the head and configured to move toward the handle from aretracted position to a deployed position, (5) a pullrod coupling thetrigger and the needles and configured to cause the needles to move, (6)a needle extension indicator associated with the handle and (7) aninjection complete indicator associated with the handle.

Another aspect provides a method of operating a rectal injection device.In one embodiment, the method includes: (1) inserting a head of thedevice into a rectum of an animal, (2) pulling back the head to causethe head to seat against an anal dentate of the rectum, (3) deploying aplurality of needles of the device from the head so that they enter therectum proximate the anal dentate and (4) injecting the fluid throughthe plurality of needles into the anal dentate.

BRIEF DESCRIPTION

Reference is now made to the following descriptions taken in conjunctionwith the accompanying drawings, in which:

FIG. 1 is a diagram of geometry involved in some embodiments of a rectalinjection device;

FIG. 2 is a diagram showing one embodiment of a rectal injection device;

FIG. 3 is a diagram showing another embodiment of a rectal injectiondevice;

FIG. 4 is an isometric view of a balloon embodiment of a head of arectal injection device in a deflated state;

FIG. 5 is an isometric view of the balloon embodiment of FIG. 4 in aninflated state; and

FIG. 6 is a sectional view of one translating-needle embodiment of ahead of a rectal injection device in a retracted position;

FIG. 7 is a sectional view of the translating-needle embodiment of FIG.6 in a deployed position;

FIG. 8 is a sectional view of another translating-needle embodiment of ahead of a rectal injection device in a retracted position;

FIG. 9 is a sectional view of the translating-needle embodiment of FIG.8 in a deployed position;

FIG. 10 is a sectional view of yet another translating-needle embodimentof a head of a rectal injection device in a deployed position;

FIG. 11 is an isometric view of a cam-driven embodiment of a head of arectal injection device in a retracted position;

FIG. 12 is a sectional view of the cam-driven embodiment of FIG. 11 in adeployed position;

FIG. 13A is a sectional view of an arm-driven embodiment of a head of arectal injection device in a retracted position;

FIG. 13B is a sectional view of the arm-driven embodiment of FIG. 13A ina deployed position;

FIG. 14A is an isometric view of a rotating-needle embodiment of a headof a rectal injection device in a deployed position;

FIG. 14B is an isolated isometric vide of the rotating needle embodimentof FIG. 14A; and

FIG. 15 is an isometric view of a conical-head embodiment of a head of arectal injection device;

FIG. 16 is an isometric view of a linear embodiment of a rectalinjection device;

FIG. 17 is an isometric cutaway view of the linear embodiment of FIG.16;

FIGS. 18A-C are isometric views of a Luer activated fill port;

FIGS. 19A and B are schematic views of two alternative priming systems;

FIGS. 20A and B are respective isometric cutaway views of the linearembodiment of FIG. 16 and a head thereof;

FIGS. 21A and B are respective isometric cutaway views of the linearembodiment of FIG. 16 and a handle thereof;

FIGS. 22A and B are respective isometric cutaway views of the linearembodiment of FIG. 16 and a handle thereof;

FIG. 23 is an isometric view of a pistol-handle embodiment of a rectalinjection device;

FIG. 24 is an isometric cutaway view of the pistol-handle embodiment ofFIG. 23;

FIGS. 25A-C are respective isometric cutaway views of the pistol-handleembodiment of FIG. 23 and a head and handle thereof;

FIG. 26 is an isometric cutaway view of the pistol-handle embodiment ofFIG. 23;

FIGS. 27A and B is an isometric cutaway view of the pistol-handleembodiment of FIG. 23 and a handle thereof;

FIG. 28 is an isometric view of a T-handle embodiment of a rectalinjection device;

FIG. 29 is an isometric cutaway view of the T-handle embodiment of FIG.28;

FIGS. 30A and B are respective isometric cutaway views of the T-handleembodiment of FIG. 28 and a head thereof;

FIG. 31 is an isometric cutaway view of the T-handle embodiment of FIG.23;

FIG. 32 is an isometric cutaway view of the T-handle embodiment of FIG.23;

FIGS. 33A-C are respective views of one embodiment of a rectal injectiondevice head;

FIG. 34 is an isometric view of a linear embodiment of a rectalinjection device;

FIG. 35 is an isometric view of the linear embodiment of FIG. 34 fromanother angle;

FIG. 36 is an isometric cutaway view of the linear embodiment of FIG.34;

FIGS. 37A and B are cutaway views of a head of the rectal injectiondevice of FIG. 34; and

FIG. 38 is a flow diagram of one embodiment of a method of using arectal injection device.

DETAILED DESCRIPTION

Introduced herein are various embodiments of a device and method forinjection to address hemorrhoids, fecal incontinence caused by analsphincter relaxation or other concerns. Many of the various embodimentsare used as follows: (1) a head of the device is inserted into therectum of a subject animal or human past the anal dentate line; (2) thedevice is then pulled back until the head contacts the dentate andinternal anal sphincter; (3) multiple needles are deployed into therectum around the internal sphincter using an actuator of some type; (4)a liquid, which may be a filler agent, a sclerosing agent, or a liquidof another type that depends upon the desired treatment, is injectedthrough the needles into or around the internal sphincter port; (5) theneedles are retracted; and (6) the device is withdrawn. In certainembodiments, the head is or becomes enlarged in terms of its diametersuch that it seats against the internal sphincter. This allows aclinician operating the device some assurance that the head is properlylocated within the patient without needing to see the head, e.g., usinga scope). Of course, a scope may be employed.

In certain embodiments, the head is bulbous. In other embodiments, thehead is conical or frustoconical.

In certain other embodiments, the device employs the multiple needles toinject multiple evenly spaced regions of the rectum with a single pass.In certain embodiments, the needles translate to deploy and retract. Inother embodiments, the needles rotate to deploy and retract. In certainembodiments, a radial flange drives the needles. In other embodiments, acam drives the needles. In yet other embodiments, one or more slidinglinkages drive the needles. In some embodiments, the needles arespring-loaded. In a few embodiments, the needles are spring-loaded suchthat they retract in the absence of another force.

In certain embodiments, the needles are evenly radially spaced; e.g.,four needles being spaced 90° apart to form four quadrants for injectionof liquid. In alternative embodiments, the needles are unevenly spaced.These embodiments may be useful in the treatment of conditions notbenefitting from, or not requiring, uniform injection. In relatedembodiments, four needles are provided. In other embodiments, differentnumbers of needles are provided.

In many embodiments, a central member drives the sliding block, cam orsliding linkage(s), allowing the needles to deploy and retractconcurrently. In many embodiments, a trigger or other manual actuator iscoupled to the central member, allowing the clinician to deploy andretract the needles.

In many embodiments, at least one reservoir contains the liquid that isultimately injected through the needles. Passages couple thereservoir(s) to the needles, allowing the liquid to flow from thereservoir(s) to the needles. In certain embodiments, the reservoir(s)are formed of one or more syringes, which may be conventional orcustom-made for the device. The passages may be common to multipleneedles, e.g., one passage for two needles or one passage for eightneedles, or may correspond one-for-one with the needles, e.g., fourpassages for four needles.

In one embodiment, the device may be used to provide an improved drugdelivery method in the treatment of gastrointestinal muscle disordersand other smooth muscle dysfunction by the injection of atherapeutically effective amount of sphincteric botulinum toxin orrelated compounds, with an improvement in efficacy provided by theplurality of needles and plurality of injection sites provided by thedevice. The improved efficacy provided by plurality of needles embodiedin the device, versus a single needle, may be thus used in the improvedtreatment of various disease conditions, including achalasia, disordersof the lower esophageal sphincter, gastroparesis, hypertrophic pyloricstenosis, sphincter of Oddi dysfunction, short-segment Hirschsprung's,anal fissure, hemorrhoids, proctalgia fugax, irritable bowel syndrome,disorders of the upper esophageal sphincter, vasospastic disorders, anddisorders of uterine and bladder spasm.

In another embodiment, the device may be used for the purpose ofproviding for SCL for esophageal varices.

In another embodiment, an optical endoscopic functionality may beintegrated with the injection array device to aid in the accuratelocation of injection sites, and to provide visualization of theinjection site during injection and drug administration. A sufficientlylow-cost camera may be used in this integration to enable thecost-effective one-time-use of the device.

In another embodiment, the device may be used in providing an improvedmethod of drug delivery used in the treatment of for treatment ofesophageal cancer. In this embodiment, the device provides an improvedmeans for the injection of certain light-sensitive materials used forphotodynamic therapy, or for the delivery of chemotherapy or othermedications to the tumor location.

FIG. 1 is a diagram of geometry involved in some embodiments of a rectalinjection device. A cylinder 100 having, for example, a 10 mm radius,represents an anal canal of a subject patient. An upper end 105 of thecylinder 100 represents an anal dentate of the anal canal 100. A line110 represents an extension tube (not shown) of an injection device (notshown) passing through the anal canal 100 along an axis parallel theretoand exiting the anal dentate into the rectum (not shown). A line 115represents a needle extending from a head (not shown) of the rectalinjection device. The line has a length 120 and a penetration depth 125.The line 115 is at a departure angle θ from the line 110. In variousembodiments for treatment of hemorrhoids or fecal incontinence, θtypically ranges from about 0° to about 90°. However, in otherembodiments, θ exceeds 90°. FIG. 1 is directed to rotating-needleembodiments (in which θ changes between deployed and retractedpositions). Accordingly, FIG. 1 indicates an x-distance 130 by which atip of the needle moves as it is rotated between a retracted and adeployed position. A root of the needle (the end opposite the tip) isdisplaced from the anal dentate by a y-distance 135.

In one embodiment, the rectal injection device has an extension tubelength of greater than 5 cm and a diameter of less than or equal to 3cm. In this embodiment, the head houses three to five needles of 23-25gauge that may be controlled individually or in tandem. The head isdesigned to seat at or near the dentate line without a camera, and havea rounded (bulbous, conical or frustoconical) head shape. It employs adownward injection angle from above the dentate line, has an injectiondepth 125 of 4-5 mm, and have a needle departure angle θ of less than45°.

FIG. 2 is a diagram showing one embodiment of a rectal injection device200. In this embodiment, the device 200 resembles a pistol. Accordingly,the device has a handle 210. The handle 210 is configured to be grippedby a human hand, allowing a clinician to control the device 200. Thedevice 200 further has an extension tube 220 that extends forward fromthe handle 210 and terminates in a head 230 at an end of the extensiontube 220 that is distal from the handle 210. The device 200 further hasa trigger 240 (including two distinct finger loops shown but notseparately referenced in this embodiment) that may be translated backtoward the handle 210 or forward toward the head 230 to deploy andretract needles (not shown) that are associated with the head 230 and atleast one reservoir 250 for containing a liquid (not shown) andeventually dispensing it through the needles into a patient (not shown).The embodiment of FIG. 2 shows four reservoirs 250 having plungers andtherefore taking the form of syringes. In the embodiment of FIG. 2, eachplunger is independently translatable; a clinician can cause eachsyringe to dispense separately. In an alternative embodiment, theplungers are ganged, e.g., with a common pusher (not shown), to allow aclinician to cause the syringes to dispense concurrently by actuatingthe common pusher. “Trigger” is broadly defined to include any structureconfigured for external actuation, whether it be by human (e.g., fingeror hand) or machine (e.g., air hose or motor).

FIG. 3 is a diagram showing another embodiment of a rectal injectiondevice 200. Again, the device 200 is pistol-like, but less so than theembodiment of FIG. 2. As before, the device 200 has a handle 210allowing a clinician to control the device 200, an extension tube 220that extends forward from the handle 210 and supports a head 230 at anend of the extension tube that is distal from the handle 210, and atleast one reservoir 250 for containing a liquid and eventuallydispensing it through needles (not shown) into a patient (not shown). Aswith the embodiment of FIG. 2, the embodiment of FIG. 3 shows fourreservoirs 250 having plungers and therefore taking the form ofsyringes. As with the embodiment of FIG. 2, each plunger isindependently translatable; a clinician can cause each syringe todispense separately. In an alternative embodiment, the plungers areganged, e.g., with a common pusher (not shown), to allow a clinician tocause the syringes to dispense concurrently by actuating the commonpusher. The embodiment of FIG. 3 does not show a trigger. However, theembodiment of FIG. 3 would include a mechanism for deploying andretracting the needles in the head 230.

Several embodiments of the head 230 of FIGS. 2 and 3 will now beillustrated and described. In general, the head 230 is intended to enterthe rectum through the anus, be lodged against the anal dentate andcontain needles that are to be deployed to effect injection andtreatment and retracted to allow the head 230 to be withdrawn from therectum.

FIG. 4 is an isometric view of a balloon embodiment of a head 230 of arectal injection device (e.g., 200 of FIGS. 2 and 3) in a deflatedstate. In the embodiment of FIG. 4, the head 230 has a generallyspherical end 405 and an annular recess 410 under the generallyspherical end 405 according to the view of FIG. 2. Balloon segments (twoof which being referenced 415, 420) reside in the annular recess 410.Passages (shown in broken line, and one of which being referenced 425)allow a gas (e.g., air) to be introduced into, and withdrawn from, theballoon segments 415, 420, causing them to inflate and deflate. FIG. 5is an isometric view of the balloon embodiment of FIG. 4 in an inflatedstate.

FIGS. 4 and 5 also show a portion of the extension tube 220 under theannular recess 410 according to the view of FIGS. 4 and 5. It will benoted that the generally spherical end 405 is about as wide as theextension tube 220 (i.e. the radius of the generally spherical end 405is approximately the same as the radius of the extension tube 220).Because the generally spherical end 405 is not substantially wider thanthe extension tube 220, rectal insertion is expected to be easier andmore comfortable to the patient. However, the balloon segments 415, 420(or some kind of radial extension) are needed to ensure that thegenerally spherical end 405 is not inadvertently withdrawn beforetreatment is complete. Embodiments of the head 230 to be illustrated anddescribed below are wider than the extension tube 220 such that itswidth requires a force to withdraw the head 230 from the rectum. This,in turn, eliminates a need for the balloon segments 415, 420.

FIG. 6 is a sectional view of one translating-needle embodiment of ahead 230 of a rectal injection device (e.g., 200 of FIGS. 2 and 3) in aretracted position. It should be noted that the head 230 is generallyconical or frustoconical and wider than the extension tube 220. Apullrod 621 is located in the extension tube 220. The pullrod 621terminates in a radial flange 622 that bears against spring-loadedneedles 624 a, 624 b so that, when the pullrod 621 is pulled (moved tothe right in the view of FIG. 6), the radial flange 622 moves to theright and urges the needles 624 a, 624 b from their retracted positionas shown in FIG. 6 to a deployed position. FIG. 7 is a sectional view ofthe translating-needle embodiment of FIG. 6 showing the needles 624 a,624 b in their deployed position. Note that the angle θ of the needles624 a, 624 b relative to the axis of the extension tube 220 is about 0°.“Pullrod” is defined broadly herein to include any structure thatcouples needles to a trigger, whether or not the pullrod pulls, pushes,rotates or moves laterally to deploy the needles.

FIG. 8 is a sectional view of another translating-needle embodiment of ahead 230 of a rectal injection device (e.g., 200 of FIGS. 2 and 3) in aretracted position. Again it should be noted that the head 230 isgenerally conical or frustoconical. Though FIG. 8 does not show theextension tube, the head 230 is wider than the extension tube. A pullrod621 is located in the extension tube 220. The pullrod 621 terminates ina radial flange 622 having a conical backside (not separatelyreferenced) that bears against spring-loaded needles (only one of whichbeing shown and referenced as 624 b) so that, when the pullrod 621 ispulled (moved to the right in the view of FIG. 8), the radial flange 622moves to the right and urges the needles (e.g., 624 b) from theirretracted position as shown in FIG. 8 to a deployed position. FIG. 9 isa sectional view of the translating-needle embodiment of FIG. 8 showingthe needles (e.g., 624 b) in their deployed position. Note that theangle θ of the needles (e.g., 624 b) relative to the axis of theextension tube 220 is between about 10° and about 30°.

FIG. 10 is a sectional view of yet another translating-needle embodimentof a head 230 of a rectal injection device (e.g., 200 of FIGS. 2 and 3)in a deployed position. Unlike the embodiments of FIGS. 6 and 8, theembodiment of FIG. 10 has a generally spherical end 405. Unlike theembodiment of FIGS. 4 and 5, the spherical end 405 is substantiallywider than the extension tube 220; thus balloon segments (or some otherstructure to hold the head 230 in place relative to the rectum) are notneeded. The pullrod 621 terminates in a radial flange 622 having abackside (not separately referenced) that bears against spring-loadedneedles 624 a, 624 b so that, when the pullrod 621 is pulled (moved tothe right), the radial flange 622 moves to the right and urges theneedles 624 a, 624 b from their retracted position (not shown) to adeployed position (shown). Note that, as with the embodiment of FIG. 8,the angle θ of the needles 624 a, 624 b relative to the axis of theextension tube 220 is between about 10° and about 30°.

FIG. 11 is an isometric view of a cam-driven embodiment of a head of arectal injection device (e.g., 200 of FIGS. 2 and 3) in a retractedposition. Needles (one of which being referenced 1131) are captured inradial races (one of which being referenced 1111) of a first (upper inthe view of FIG. 11) member 1110. Distal ends of axles (one of whichbeing referenced 1130), associated with the needles (e.g., 1131) arecaptured in helical races 1121 of a second (lower in the view of FIG.11) member 1120. As the first and second members 1110, 1120 rotaterelative to one another in a first direction (the first member 1110rotating clockwise relative to the second member 1120 in the embodimentof FIG. 11), the needles (e.g., 1131) are deployed from within theradial races (e.g., 1111) of the first member 1110. As the first andsecond members rotate relative to one another in a second, oppositedirection (the first member 1110 rotating counterclockwise relative tothe second member 1120 in the embodiment of FIG. 11), e.g., 1131) areretracted into the radial races (e.g., 1111) of the first member 1110.The orientation of the helical races (e.g., 1121) determines therelative direction in which the first and second members 1110, 1120 arerotated relative to one another to deploy and retract the needles (e.g.,1131). The angle of the helical races (e.g., 1121) determines the rateat which the needles (e.g., 1131) are deployed and retracted relative tothe motion of the first and second members 1110, 1120. FIG. 12 is asectional view of the cam-driven embodiment of FIG. 11 with the needlesin their deployed position.

FIG. 13A is a sectional view of an arm-driven embodiment of a head 1310of a rectal injection device (e.g., 200 of FIGS. 2 and 3) in a retractedposition. FIG. 13B is a sectional view of the arm-driven embodiment ofFIG. 13A in a deployed position. Needles (only one of which being shownin FIGS. 13A and 13B and referenced as 1320) are provided with rigidshafts (only one of which being shown in FIGS. 13A and 13B andreferenced as 1330) containing the passages and extending into theextension tube (not shown). The shafts (e.g., 1330) are coupled to arms(only one of which being shown in FIGS. 13A and 13B and referenced as1340) that, when the shafts (e.g., 1330) are drawn downward as shown,the arms (e.g., 1340) cause the needles (e.g., 1320) to slide radiallyoutward as shown.

FIGS. 6-13B do not show the passages that couple the needles to thereservoir(s). This is to keep FIGS. 6-13B relatively simple. Thoseskilled in the pertinent art will understand how to provide passages forliquid flow from the reservoir(s) to the roots of the needles, using,e.g., flexible plastic tubing. Also, the needles translate to deploy andretract in the embodiments of FIGS. 6-12. Now embodiments in which theneedles rotate to deploy and retract will be described.

FIG. 14A is an isometric view of a rotating-needle embodiment of a head230 of a rectal injection device (e.g., 200 of FIGS. 2 and 3) in adeployed position. Needles (one of which being referenced 1410) arecoupled to passages (one of which being referenced 1420) that take theform of flexible shafts. A cage 1430 is coupled to the root (notreferenced) of each of the needles (e.g., 1410). The needles (e.g.,1410) pass through apertures (not referenced) in the head 230 as shown.The cage 1430 and the needles (e.g., 1410) cooperate such that, as thecage 1430 is drawn back from the head 230 under the urging of a pullrod1440, the needles (e.g., 1410) extend through the apertures and rotateoutwardly to deploy. FIG. 14B is an isolated isometric vide of therotating needle embodiment of FIG. 14A showing the needles (e.g., 1410),passages (e.g., 1420), cage 1430 and pullrod 1440 in isolation. Whentreatment is complete, the pullrod 1440 advances the cage 1430, and theneedles (e.g., 1410) rotate inwardly as they retract back into the head230.

FIG. 15 is an isometric view of a conical-head embodiment of a head 230of a rectal injection device (e.g., 200 of FIGS. 2 and 3). FIG. 15 ispresented primarily for the purpose of showing a head 230 having aconical or frustoconical shape, together with the extension tube 220that supports it.

FIG. 16 is an isometric view of a linear embodiment of a rectalinjection device 200. The device 200 has an elongated handle 210, anextension tube 220 extending from the handle 210 and a head 230. Thehandle 210 is configured to be gripped by a human hand. The head 230 isconfigured to be inserted into a rectum of an animal, which may be ahuman, treat the rectum with an injection via a plurality of needles(not shown in FIG. 16) and be withdrawn from the rectum.

In the illustrated embodiment, the head 230 is bulbous. The extensiontube 220 supports the head relative to the handle 210. A trigger 240extends laterally from the handle and is configured to be moved toextend a plurality of needles (not shown) from within the head. In theillustrated embodiment, the trigger 240 is located beneath the handle210 and configured to be translated away from the head 230 to extend theplurality of needles. An auto injection button 1610 also extendslaterally from the handle and is configured to be depressed to cause afluid, which may be a sclerosant, to flow from the device 200 throughthe plurality of needles. In the illustrated embodiment, the autoinjection button 1610 is opposite the handle from the trigger, andtherefore over the handle, as shown.

Three indicators are shown in the handle. From left to right, they are:a needle extension indicator 1620 configured to indicate whether or notthe plurality of needles are deployed, an injection complete indicator1630 configured to indicate whether or not the injection of fluid iscomplete and a syringe window 1640 configured to allow an outsideobserver (e.g., a person operating the device) to inspect an internaldevice syringe (not shown in FIG. 16) within the handle 210.

FIG. 17 is an isometric cutaway view of the linear embodiment of FIG.16. FIG. 17 illustrates a pullrod 621 within the extension tube thatactuates a plurality of needles (shown but not referenced in FIG. 17).An auto needle retract spring 1710 is configured to urge the pullrod 621toward the head 230 and, accordingly, the plurality of needles toward aretracted position. FIG. 17 also shows how, in the illustratedembodiment, a flange 1720 associated with the trigger 240 is configuredto interact with the auto injection button 1610 to prevent the autoinjection button 1610 from being actuated until the trigger 240 has beenpulled away from the head 230 a given distance.

FIG. 17 further shows an internal device syringe 1730 having an autoinject spring 1740 associated with a plunger (not referenced) thereof toallow the plunger to be activated automatically to cause fluid to flowout of the internal device syringe 1730 and through the plurality ofneedles when the auto injection button 1610 is depressed.

FIG. 17 also shows a fluid delivery system including a Luer activatedfill port 1750, a check valve 1760 and tubing (unreferenced). The fluiddelivery system is configured to allow fluid to be received from a fillsyringe (not shown) and delivered to the internal device syringe 1730and the needles. Those skilled in the pertinent art are aware of Lueractivated fill ports. A Luer activated fill port is configured to deformin response to an applied pressure (typically from a fill syringe) toopen and to reseal when the pressure is withdrawn. FIGS. 18A-C areisometric views of a Luer activated fill port (having an outer seal 1810and an inner seal 1820) showing the Luer activated fill port inrespective closed, partially open and fully open configurations inresponse to applied pressure from a fill syringe 1830, allowing fluid1840 from the fill syringe 1830 to pass through the port.

FIGS. 19A and B are schematic views of two alternative priming systems.In the embodiment of FIG. 19A, the valve 1760 is a check valve having acracking pressure greater than the pressure needed to fill the internaldevice syringe 1730. Thus, the fluid from the fill syringe 1830 entersthrough the Luer activated fill port 1750, first fills the internaldevice syringe 1730, then the check valve 1760 opens, allowing the fluidfrom the fill syringe 1 to fill the rest of the priming system andplurality of needles.

In the alternative embodiment of FIG. 19B, the valve is a manual valve1760 configured to be manually closed to allow fluid from the fillsyringe 1830 to fill the internal device syringe 1730, then manuallyopened to allow the fluid from the fill syringe 1830 to fill the rest ofthe priming system and plurality of needles.

FIGS. 20A and B are respective isometric cutaway views of the linearrectal injection device 200 embodiment of FIG. 16 and a head 230thereof. Once the device 200 has been primed with fluid, the device 200is ready for treatment. Accordingly, the device 200 is intended to beinserted into the rectum of a patient (not shown) and pulled backslightly until the head 230 comes back to rest against the anal dentatethereof. The trigger 240 may then be pulled away from the head 230 as anarrow in FIG. 20A shows, causing the pullrod 621 to be pulled away fromthe head 230 and causing the plurality of needles 624 a, 624 b to extendfrom the head 230 into a region about the anal dentate as FIG. 20Bshows. It will be noted that, in FIG. 20A, the trigger 240 has beenpulled away fully, causing the needle extension indicator 1620 toindicate a full extension of the plurality of needles 624 a, 624 b andfurther causing a flange 1720 of the trigger 240 to align with the autoinjection button 1610, unlocking the auto injection button 1610 fordepression thereof.

FIGS. 21A and B are respective isometric cutaway views of the linearrectal injection device 200 embodiment of FIG. 16 and a handle 210thereof. FIG. 21A shows the auto injection button 1610 fully depressed,which, as FIG. 21B shows, has a feature 2110 that translates down to allan auto injection mechanism 2120 to become unlatched. This unlatching,in turn, releases the auto inject spring 1740 in the internal devicesyringe (not referenced) to relax, compressing the plunger within theinternal device syringe and pressurizing the fluid therein. Thispressurizing causes the fluid to be delivered to and through theplurality of needles.

FIGS. 22A and B are respective isometric cutaway views of the linearrectal injection device 200 embodiment of FIG. 16 and a handle 210thereof. FIG. 22A shows the plunger (not referenced) close to or at theextreme end of its compressive travel, causing the injection completeindicator 1630 to indicate a full extension of the plurality of needles.FIG. 22B shows that, once the plunger is close to or at the extreme endof its compressive travel, the pullrod 621 is released, causing theplurality of needles to retract automatically under the urging of theauto needle retract spring, and causing the needle extension indicator1620 to indicate that the needles have retracted. The head 230 of therectal injection device 200 may then be withdrawn from the patient. Alocking mechanism 2210 engages the pullrod 621 to prevent it from movingagain, rendering the rectal injection device 200 a one-time-use device.In one embodiment, the device is disposable, and perhaps made ofrecyclable materials.

FIG. 23 is an isometric view of a pistol-handle embodiment of a rectalinjection device 200. The pistol-handle embodiment is similar in manyways to the linear embodiment of FIG. 16. However, two differences maybe noted in FIG. 23. First, there is no auto injection button. Second,the handle includes a pistol handle 210 protruding therefrom, e.g., atan acute angle.

FIG. 24 is an isometric cutaway view of the pistol-handle embodiment ofFIG. 23. Further differences between this embodiment and that of FIG. 16are now apparent. Primarily, the trigger is configured to rotate ratherthan translate, changing the way the trigger actuates the device.

FIGS. 25A-C are respective isometric cutaway views of the pistol-handlerectal injection device 200 embodiment of FIG. 23 and a head 230 andhandle 210 thereof. After priming as with the linear embodiment of FIG.16, the trigger 240 may be actuated. Actuation of the trigger 240 (asFIG. 25A shows) actuates a linkage 2410, forcing the pullrod 621 totranslate away from the head 230 (as FIG. 25B shows) against the urgingof the auto needle retract spring 2420 and causing the plurality ofneedles to extend from the head (as FIG. 25C shows). The needleextension indicator 1620 indicates the extension of the needles.

FIG. 26 is an isometric cutaway view of the pistol-handle embodiment ofFIG. 23. Actuation of the trigger further forces, through a linkage2610, the plunger of the internal device syringe 1730 to compress,causing the fluid in the internal device syringe 1730 to flow toward,through and out the plurality of needles.

FIGS. 27A and B are an isometric cutaway views of the pistol-handlerectal injection device 200 embodiment of FIG. 23 and a handle 210thereof. Once the plunger is close to or at the extreme end of itscompressive travel, the linkage 2410 holding the pullrod 621 in itsposition is released, causing the pullrod 621 to move back toward thehead and the plurality of needles to retract automatically under theurging of the auto needle retract spring (not shown).

FIG. 28 is an isometric view of a T-handle embodiment of a rectalinjection device. The T-handle embodiment is similar in many ways to thelinear embodiment of FIG. 16. However, four differences may be noted inFIG. 28. First, there is no auto injection button (1610 of FIG. 16).Second, the trigger 240 is bifurcated into two symmetric triggerportions. Nonetheless, the trigger will be referred to in the singular.Third, a T-handle 210 protrudes from a rear portion of the device 200.Fourth, the Luer activated fill port 1750 is mounted on one side of theT-handle 210 instead of an end of the device 200.

FIG. 29 is an isometric cutaway view of the T-handle embodiment of FIG.28. Like the embodiment of FIG. 16, the trigger 240 is configured totranslate.

FIGS. 30A and B are respective isometric cutaway views of the T-handleembodiment of FIG. 28 and a head thereof. After priming as with thelinear embodiment of FIG. 16, the trigger may be actuated. As thetrigger is actuated, an O-ring 3010 associated with the pullrod 621 isconfigured to drag frictionally on the pullrod 621 to urge the pullrod621 away from the head 230 and urge the plurality of needles into, andmaintain the plurality of needles in, an deployed position while thefluid is being delivered through the plurality of needles. Actuation ofthe trigger 240 concurrently causes the plunger of the internal devicesyringe to compress, causing the fluid in the internal device syringe1730 to flow toward, through and out the plurality of needles.

FIG. 31 is an isometric cutaway view of the T-handle embodiment of FIG.23. FIG. 31 shows that the O-ring 3010 drags frictionally along thepullrod 621 to maintain the plurality of needles in an deployed positionwhile the fluid is being delivered through the plurality of needles.

FIG. 32 is an isometric cutaway view of the T-handle embodiment of FIG.23. Once the trigger 240 and plunger (not referenced) are close to or atthe extreme end of their travel, the O-ring falls free from the pullrod621, causing the pullrod 621 to move back toward the head 230 and theplurality of needles to retract automatically under the urging of theauto needle retract spring (not shown in FIG. 32).

FIGS. 33A-C are respective views of one embodiment of a rectal injectiondevice head. FIG. 33A is an exploded view showing the needles (two ofwhich being referenced 624 a, 624 b) embedded in needle carriers (one ofwhich being referenced 3310), which allow the needles (e.g., 624 a, 624b) to be captured in corresponding bearings 3320 at an end of thepullrod 621. A corresponding plurality of ramps on an insert 3330 of thehead 230 maintain the orientation of the plurality of needles (e.g., 624a, 624 b). FIGS. 33B and 33C show the plurality of needles (e.g., 624 a,624 b) in retracted and deployed positions, respectively, while thepullrod 621 is translated from a more proximal position in FIG. 33B to amore distal position in FIG. 33C.

FIG. 34 is an isometric view of a linear embodiment of a rectalinjection device 200. A few differences will be noted between theembodiment of FIG. 34 and the embodiment of FIG. 16. First, the handle210 is curved to fit a human hand and hence more ergonomic. Second, ascale 3410 is printed on the extension tube 220 to assist the personoperating the device 200 in determining the distance to which the device200 has been inserted into a patient. It is also apparent that thisembodiment of the device 200 has ornamental features not related to anyof its functionality; it is attractive as well as useful. FIG. 35 is anisometric view of the linear embodiment of FIG. 34 from another angle.

FIG. 36 is an isometric cutaway view of the linear embodiment of FIG.34. FIG. 36 is similar in many ways to FIG. 17 and will not be describedfurther.

FIGS. 37A and B are cutaway views of a head of the rectal injectiondevice of FIG. 34 with a cover of the head 230 removed to show thepullrod 621, the bearings 3320, the insert 3330 and the plurality ofneedles (unreferenced) in the head and the relationship between theextension tube and the head. FIG. 37A shows the needles in a retractedposition, and FIG. 37B shows the needles in an deployed position.

FIG. 38 is a flow diagram of one embodiment of a method of using arectal injection device. The method begins in a start step 3810. In astep 3820, the device is primed with a fluid, e.g., a sclerosant. In astep 3830, a head of the device is inserted into a rectum of an animal,e.g., a human. In a step 3840, the head is pulled back to cause the headto seat against the anal dentate of the rectum. In a step 3850, aplurality of needles of the device are deployed from the head so thatthey enter the rectum proximate the anal dentate. In a step 3860, thefluid is injected through the plurality of needles into the analdentate. In a step 3870, the plurality of needles are retracted backinto the head. In a step 3880, the head of the device is withdrawn fromthe rectum. The method ends in an end step 3890.

Those skilled in the art to which this application relates willappreciate that other and further additions, deletions, substitutionsand modifications may be made to the described embodiments.

What is claimed is:
 1. A method of operating a rectal injection device,comprising: inserting a head of said device into a rectum of a mammal;pulling back said head to cause said head to seat against an analdentate of the rectum; deploying a plurality of needles of said devicefrom said head so that they enter said rectum proximate said analdentate; and injecting said fluid through the plurality of needles intosaid anal dentate.
 2. The method as recited in claim 1 furthercomprising priming said device with a fluid.
 3. The method as recited inclaim 2 wherein said fluid is a sclerosant.
 4. The method as recited inclaim 1 wherein said mammal is a human.
 5. The method as recited inclaim 1 further comprising retracting said plurality of needles backinto said head.
 6. The method as recited in claim 1 further comprisingwithdrawing said head of said device from said rectum.
 7. The method asrecited in claim 1 further comprising employing a needle extensionindicator to determine whether said plurality of needles are deployed.8. The method as recited in claim 1 further comprising manuallycontrolling a rate of said injecting.
 9. The method as recited in claim1 further comprising employing an injection complete indicator todetermine whether said injecting has been fully carried out.